This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
83
The research team will introduce themselves and ask the parents to watch an informational video explaining the ViDES study on an iPad while they stay in the room with the parents. After viewing the video, the team will answer any questions and provide written consent and enough time to decide whether to participate in the study. The research team will also provide a QR code that grants parents/guardians access to the video on their own device at any time. This allows them to pause, rewind, and revisit the information.
The research team will present a detailed explanation of the ViDES study, answer questions, provide written consent, and provide enough time to decide on participation or not in the study.
McGovern Medical School at UTHealth Houston
Houston, Texas, United States
ViDES trial consent rate
Time frame: Within 1 week of the intervention
Participants' understanding of the ViDES study as assessed by a questionnaire
The questionnaire assesses recall of possible benefits and risks of participation.
Time frame: Within 48 hours of the intervention
Participants' satisfaction with consent approach as assessed by a questionnaire
The questionnaire assesses satisfaction with ability to ask questions and decision time.
Time frame: Within 48 hours of the intervention
Participant's opinions related to participation in research as assessed by a questionnaire
The questionnaire assesses participant's opinions related to participation in research and research being part of the care of infants.
Time frame: Within 48 hours of the intervention
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